# FDA recall Z-1386-2022

> **Stryker Neurovascular** · Class II · device recall initiated 2022-06-03.

## Product

Trevo Trak 21 Microcatheter, REF: 90338.    TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412;  TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;  TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414;  TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415;  TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170  TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, REF: SFP914190.   Used in the placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

## Reason for recall

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT.

## Key facts

- **Recall number:** Z-1386-2022
- **Recalling firm:** Stryker Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-03
- **Report date:** 2022-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2022

## Citation

> AI Analytics. FDA recall Z-1386-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1386-2022. Source: US FDA. Licensed CC0.

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